In 2019, the African Union’s Bureau of Heads of State and Government approved a new Treaty for the establishment of the African Medicines Agency (AMA) to improve countries’ ability to regulate medical products. It appeared like AMA will become a reality now that 15 African Union Member States have ratified the Treaty in recent months. …
Integral health integrates traditional treatment in a coordinated way with alternative medicine. Multimodal interventions, which combine two or more interventions such as conventional medicine, lifestyle changes, physical rehabilitation, psychotherapy and complementary health approaches in various combinations, with an emphasis on treating the whole person rather than, for example, one organ system, are also emphasized in …
Knowledge management (KM) has been a recognized discipline in other sectors for over 20 years, but it has taken a long time for the biopharmaceutical business to debate and formalize it. When the ICH guideline paper Pharmaceutical Quality System: Q10 was published in 2008, it highlighted knowledge management as a major enabler of a pharmaceutical …
Knowledge Management in Regulatory Affairs (KMRA) Read More »
The COVID-19 pandemic has forced healthcare systems to drastically and quickly rethink how they offer care. The unusually rapid spread of telehealth has been one of the most astonishing continuing trends. The pandemic may offer the impetus required to fulfill telehealth’s full potential. Nonetheless, there are fears that fast deregulation might jeopardize safety and privacy, despite …
With a laser-like emphasis on results and value, healthcare is fast moving to a new world of patient choice. Indeed, healthcare systems that have historically emphasized medical treatments based on episodic interactions with patients are now realizing the need to fully comprehend external variables and provide ongoing care. Exogenous factors like genomics, conduct and social …
One of the fastest expanding technologies on the planet at present is Artificial Intelligence (AI). It has been gaining so much popularity lately that even industry and sector have applications and use cases for it. Even from smart factories using AI to ramp up their production efforts, to the smart assistant in people’s smartphones, AI …
Artificial Intelligence – Impact on The Global Pharma Industry Read More »
IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally recognized framework for uniquely identifying and describing pharmaceutical items, as well as for standardized documentation, coding and product information interchange across global regulators, manufacturers, suppliers …
Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA Read More »
The US Food and Drug Administration (FDA) has recently finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence (CC) process. This guidance finalizes the draft guidance issued in Nov 2017 and replaces the finalized guidance issued in September 2015. This update on controlled correspondence with FDA …
The US generic drug industry has grown into a major component of health care, with generic drugs accounting for the vast majority of retail drug prescriptions dispensed. On August 18, 2017, the President of the USA signed into law the Food and Drug Administration Reauthorization Act (FDARA) including the reauthorization of the Generic Drug User …
The pharmaceutical industry is one of the most important industries that will be directly impacted by Brexit. When the United Kingdom’s referendum was held in June 2016, the majority of the British electorate voted for the withdrawal of the UK from the European Union (EU) and now Brexit is a reality. Brexit and its potential …
